HK40075248A - Bisymmetric comparison of sub-epidermal moisture values - Google Patents

Description

DISYMMETRIC COMPARISON F SUB-EPIDERMAL MOISTURE VALUES

CROSS-REFERENCE TO RELATED APPLICATIONS

[00011 This application waims the benefit of priority of U.S. Provisional Application 62/454,455 filed Febraary 3, 2017, and U.S. Provisional Application 62/521,871 filed June 19, 2017, each of which is herein incorporated by reference in its entirety.

FIELD

100021 The present disclosure provides apparatuses and computer readable media for measuring sub-epidermal mot suite in patients toidentify damaged tissue for clinical intervention. Die present disclosure also provides methods for deteuraning damaged USSUC.

BACKGROUND

[0003] The skin is the largest organ in the human body It is readily exposed to kinds of damages and injuries When the skin and its surrounding fissues are unab redistribute external pressure and mechanical forces, ulcers may be formed. Prolonged continuous exposure to even modest pressure such as the pressure created by the body weight of a supine pattern on their posterior skin surfaces.may lead to a pressure ulcer In the presence of other damage, such as the neuropattly and peripheral tissue weakening that can be induced by diabetes, even periodic exposure to moderate lc cis of pressuate and stress ci to an ulcer, for example a foot ulcer 100041 Pressure ulcers are developed by approximate]. ri 5 million people a _ ear in the United States and an equivalent number in the European Union. In long-term Sand critical-care settings, up to 2.5% of elderly and immobile patients develop pressure ulcers Approximately 60,000 Jr.S. patients die per year due to infection and other complications from pressure ulcers 100051 Detecting tissue damage before the skin breaks and intervening with the applopnate therapy to avoid further deterioration ofthe underlying tissue is desirable not only for the patient hut society The average cost of treating pressure-induced damage at the eathest visible sign In Stage 1 ulcer)is only $2,000 but this rises to $129,000 when the ulcer is deep enough to expose muscle or hone (a Stage 4 ulcer.) The current standard to detect pressure ulcers is by visual inspection, which subjective, unreliable, untimely, and lacks specificity.

SUMMARY

[00061 n aspect, the present, disclosure provides for, and includes, an appa * identifying damaged tissue, the apparatus comprising a first and a second sensors,. where the sensors each comprises a first electrode and a second electrode, and where each of the sensors is configured to be placed against a patent's skin; a circuit electronically coupled to the first and second electrodes and configured to me,asure an deetrical property between the first and second electrodes of each of the sensors and provide information regarding the electrical property* a processor electronically coupled ro the circuit and configured to receive the information from the circuit and convert the information into a sub-epidermal moisture ($EM) value and a non-transitory computer-readable rnedittill electronically coupled to the processor and comprising, instmctions *stored thereon that when executed on the processor, perform the step of; determining a difference between a first SEM value corresponding to the electrical property as measured by the first sensor at a first location on the patient's skin and a second SEM value con-espoading to the electrical property as measured by the second sensor I 4 second location on the patient's skin, where the second location is his) inntefric relative to the firgt location, 100071 In an aspect, an apparatus for identifying damaged tissue lS provided y the ptcser disclosure, the apparatus comprising', a substrate configured to be placed against a surface of a patient's skin, a plurality of sensors that are disposed on the substrate at a respective plurality of positions, where each sensor comprises a pair of electrodes, a-circuit electronically coupled to the pair of electrodes of each of the plurality of sensors and configured to measure an electrical property between the pairs of electrodes of a portion of the plurality of sensors and provide information regarding the measured electrical properties; a processor electronically coupled to the circuit and configured to receive the infoimation regarding the electrical properties from the circuit and convert the plurality of electrical pmperties into a respective plurality of sub-epidermal moisture (SEM) al u e s and a non-transitory computer-readable medium electronically coupled to the processor and comprising instnjctions stored thereon that when executed on the processor, perform the steps of identifying from the plurality of SEM values a first sensor and a second sensor that are located at first and second positions that are bi symmetric with respect to The patient's skin, and comparing a first SEM value that is associated with the first sensor with a second SEM value that is associated with the second sensor.

100081 In one aspect_ all apparatus for identifying damaged tissue is provided by the present disclosure, the apparatus comprising an apparatus body: two sensm's comprising a first sensor and a second sensor, where the two sensors are disposed on the apparams body to allow simultaneous positioning of the first sensor on a first location on a patient's skin wit' the second sensor on a second location bi symmetric relative to the first location; a circuit electronicalls coupled to each of the two sensors and configured to measure an electrical property from each of the two sensors: a processor electronically coupled to the circuit and is configured to receive a first electrical property measurement from a first locab on and a second electrical property measurement from a second location, and to convert the first electrical property measurement to a first SEC] value and the second dectri cal property' measurement into a second SENT value; a non-transitory computer-readable medium electronically coupled to the processor and contains instructions that, when executed on the processor, perform the step of determining a difference betveeeri the first SEM value and the second SEM value 100091 In an aspect a method for identifying damaged tissue is provided by the present disclosure, the method comprising obtaining a first sub-epidermal moisture ISEM3S'alue from a first location on a patient's skint; obtaining a second SEM value from a second location that is bisymmetric relative to the first location, determining a difference between a first SEM value and a second SEM value,

10, BRIEF DESCRIPTION OF THE DRAWINGS

00101 Aspects of the disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and are for purposes of illustrative discussion of aspects of the disclosure. In this regard, the description and the drawings, considered alone and together, make appal em to those skilled in the an hoyk

aspects of the disclosure may be practiced.

[0011] Figure IA is an illustration of a plan view of a toroidal sensor, [0012] Figure 111 illustrates a cross-sedion of the toroidal sensor of Figure IA.

100131 Figure IC illustrates an idealized field map created by the toroidal sensor of Figure IA when activated.

[0014] Figure 2A provides an example of a pair of bi symmetri ocati ons on a sad -al region. akording to the present disclosni-e, [0015] Figure, 2B provides an example of a pair of bisyrntllaric it:IC:M.4MS on the bottom side of both feet according to the present disclosure 100161 Figure 2C provides an example of a pair of hisvinmetric locations on the latcral sides and soles of both feet acCOrding to the present disclosure, [0017] Figure 3 is an illustration plan apparatus comprising one coaxial sensor.

100181 Figure 4A is a first exemplary apparatus comprising two sensors according to the present disclosure.

[0019] Figure 4B is a second exemplary apparatus comprising two sensors and is configured to determine SEM values at bisyrnmetriclocations according to the present disclosure.

[00201 Figure 5 is an exemplary apparatus comprising a plurality of sensors according to the

present disclosure.

[00211 Figure 61s. a first exemplary array of electrodes [0022] Figure 7 is an exemplary array of electrodes according to the present disclosure. [00231 Figure SA illustrates a first example of how the array of electrodes disclosed in Figure 7 is configured to form a sensor according to the present disc]osure.

[0024] Figure 813 illustrates a second example of how the array of electrodes disclosed in Figure 7 is configured to form a sensor according to the present disclosure.

[00251 Figure 9A illustrates an example of a first sensor formed in an array of electrodes according to the present disclosure.

[0026] Figure 913 illustrates an example of how a second sensor is formed to overlap with the first sensor of Figure 9A according to the present disclosure.

[00271 Figure 10 shows an example of how sensors as shown in Figure 8A are formed from an array of electrodes that is larger than the portion of the patient's skin that is being positioned against the array, according to the present disclosure.

[0028] Figure 11A illustrates locations on the left and right feet for SEM measurements

according to the present disclosure,

[00291 Figure 1113 is a plot of SEM values associated with known relative locations for identifying bisymnietinc locations according to the present disclosure.

[0030] Figure I2A shows an exemplary configuration of' a substrate shaped to be positioned in a known position on a patient's skin according to the present disclosure.

100311 Figure 1211 shows a front view of the exemplary configuration of Figure.12A according to the present disclosure, [0032] Figure 13 depicts an integrated system for measurement evaluation, storage, and transfer of 8E1\1 values, according to the present. disclosure,

DETAILED DESCRIPTION

10033] This description is not intended to be a detailed catalog of atI the.differe.ntways which the disclosure may be implemented, or all the features that may be added to the instant disclosure. For example, features illustrated with respect to one embodiment maw be incorporated into other embodiment, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. Thus, tbe disclosure contemplates that in some embodiments of the disclosure, any feature or combination of feattnes set Conti herein can be excluded or omitted. hi addition, Illifinerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the instant disclosure. In other instances, well-known suuctures, interfaces, and processes have not been sholyn in detail in order ntt to unnecessarily, obscure the hwenti on. ended that no part of this specification be construed to effect a disavowal of any part of the full scope of the nvention Hence, the F. following descriptions are intended to illustrate some particular.eniboØi merits of the disclosure, and not to exhaustively specify, all permutations, combinations and variations Thereof [00341 Unless Otherwise d d, all technical itic terms used herein have the same meaning as commonly understood by (ale of ordinary skill in the art to which this disclosure belongs. The terminology used in the description of the disclosure herein is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of the disclosure [00351 All publications, patent applications, patents and other references cited herein are incorporated by reference in their entireties for the teachings relevant to the sentence and/or para,graph in which the reference is presented. References to techniques employed herein are intended to refer to the techniques as commonly understood in The art, including variations on those techniques or substitutions of equivalent techniques that would be apparent to one of kiil in the art [0036] US, Patent Application Serial No 14 827,175 discloses an apparatus that uses radio frequency (RF) energy to measure the sub-epidermal capacitance using:'a bipolar sensor similar to the sensor 90 shown in Figure 1.here the sub-epiderinal capacitance corresponds to the moisture content of the target region of skin of a patient. The '375 application also discloses an array of these bipolar sensors of -various sins Patent Application Serial No 5/134,110 disdoses an apparatus for measuring sub-epidermal moisture (SEM) similar to the device shown in Figure 3. where the device emits and receives an RP signal at a frequency of 32 kHz through a single coaxial. sensor and $ a broimpedance signal. then converts this signal to a SEM value.

[0(138] Both U,S. Patent Application Serial Nos I 4/827,375 and 15/134,110 are ncorporated by reference in their entireties.

10039J Unless the context indicates otherwise, it is specifically intended that the various features of the disclosure described herein can be used in any combination. Moreover, the present disclosure also contemplates that in some embodiments of the disclosure, any feature or combination of features set forth herein can be excluded or omitted.

100401 The methods disclosed herein include and comprise one or more steps or actions mr.0 achieving the described method The method steps and/or actions may be interchanged with one another without departing from the scope of the present invention. In other words, -unless a specific order of steps Or actions is required for proper operation of the embodiment the order andior use of specific steps and/or actions may be modified without departing from the scope of the present invention [0041] As used in the description of the disclosure and the appended claims, the singular forms "a: "an" and "the" are intended to include the plural forms as well, unless ontext dearly indicates otherwise [0042] As used herein, "and/or" refers to and encompasses any and all possible combinations ne or more of the associated listed items, as well as the lack of combinations when eted in the al ternative ("or") [0043][ [he terms -about" and approximate1y as used herein when referring to a measurable value such as a length a frequency, or a SEM Value and the like, is meant to encompass variations of -I 20?0, 10%, 1 5%. ---1%, -± 0 5.), or even ± 0 1% of the specified amount [00441 As used herein, phrases such as -between X and y" and "between about X and Y" should be interpreted to include X and V. As used herein, Phrases such as -between abemt X and r mean "between about X and about r and phrases such as 'from about X to mean "from about X to about Y [00451 AS used herein. the term sub-emdermal moisture' or "SUM" refers t&thô increase in tissue fluid and local edema caused by vascular leakiness and other changes that iiadil''.the underlying structure of the damaged tissue in the presence of continued presstn-e on tissue, apoptosis, necrosis, and the inflammatory process 100461 As used herein, a -syste ' may b 11e on óf:dè.vicea in 4red orc.iréIess communication with each other.

100471 As used herein, "interrogate' refers to the use of radiofrequency energy to penetrate into a patient's skin.

[0048] As used herein, a'patient may be a human or arumal subject.

100491 As used herein, "big) mmetrie" refers to a pair ofloeanous that are appioxitnately equidistant from a line of symmetry.

[0050] As used herein. "delta" refers to a calculated difference between two SEIvi values. [0051] Figure I A is a plan view of a toroidal sensor 90 comprising a center electrode 110 and fCI a ring electrode 120. En an aspect, electrodes 110 and 120 are disposed on a common surface of a substrate 100, as depicted in the *cross-section of sensor 90 shown in Figure 113 In one aspect, substrate 100 is rigid, for example a sheet of FR4 printed circuit board (PCB). In an aspect, substrate 100 is flexible, for example a sheet of polyirnide. M one aspect, substrate 1.001s a combination of id and flexible elements. ln an aspect, electrodes 11 0 and 120 are covered xyith a cover layer 130 that is non-conductive so as to isolate electrodes 110 and 120 from each other and/or from external contact. I aspect, portions of cover layer 130 are directionally conductive, enabling electrodes 110 and 120 to be in electrical contact with an object disposed CM cover layer 130 while remaining electrically isolated from adjacent odes la an aspect, cover layer 130 is rigid and planar, thereby providing a flat external surface. In one aspect CoVer layer 130 conforms to the underlying electrodes 110 and 120 and substrate 100 such that there is nO gap or air space between substrate* 100 and cover layer 130. When an electric voltage is applied across electrodes 110 and 120, an dechie eld 140 is generated between electrodes 110 and 120 that extends outward from the plane of electrodes 110 and 120 to a distance 150, also referred to the depth of field, as shown in Figure The diameter of center electrode t 10,* the iimer and outer diameters of ring electrode 120 and the gap between electrodes 110 and 1440 may be varied to change characteristics of field *140, for example the depth of ii.id 150.

[0052] Figure 2A depicts the sacral region of the back of a patient10. A line of symmetry 12 can be drawn down the center of the back, dikiding the back into left and light mirror images..

Locations 14 are approxiniately the same distance from line of symmetry 12 and approximately at the same height and are, therefate, considered to be bisymmetric locations on the back of patient I 0, 100531 Figure 28 depicts left foot 20L and right foot 20R of a patient 10, as seen if patient 10 were I v'ng on the back on a bed (not shown) and an observer were s tiding at the foot of the bed. With reSpeCt LO SDICS 22L and 22R of fect 201_, and 20R, locaticms 241 and 24R are located at approximately equi alent locations., ag. the same distance i'roin the posterior surface, I e the heel, and the same distance front the medial side of respective foot 20L or 20R and are considered to be bisyrn metric locations.

[0054] Figure 2 depicts additional exemplary bisymmetric locations 26L and 26R located on the lateral sides of feet 20L and 20R, mid bisymmetric locations 28L and 28R located OD respective SOICS 22L and 22R of feet 20L and 20R. In an aspect, locations 26R and 3OR ECO considered hisrlimetric with respect to foot 20-R when considered alone without reference to foot 20L [005511 Without being limited to a paiticular theory, comparison of SEM measurements taken at hisymmetric locations can compensate for an offset of readins of a particular patient from a population of patients. For example, a patient may be dehydrated on.a,particular day when measurements are being made A comparison of tieE. SEM value of healthy tissue from thefl same patient, while in a dehydrated condition, may be shifted from the SEM value of the same tissue at the same location when the patient is fully hydrated If the tissue at one location is healthy while the tissue at the hi symmethe location is damaged, a comparison of the readings taken at the bisymmetric locations will exclude the "common mode" effect of dehydration on both locations and provide a more robust indication that tissue is damaged at One Location.

[0056] Figure 3 depicts exemplary SF,Tvl measurement apparatus 170 comprising one toroidal sensor 174 disposed on underside 172 of an apparatus body Apparatus 170 may be used to take measurements at multiple locations, for example a first measurement at a tint location and a second -measurement at a second location that is hisymtneiric relative to the first location In an aspect apparatus [70 comprises a processor that can be configured by instructions stored on a non-transitory computer-readable medium to determine a characteristic of the measurements taken at multi e locations or parameters associated with or derived from the measurements, for example one or more of a difference between, an average of, or a difference of each from a common average of SEM values respective' v derived froin multiple measurements. 111 one aspect, apparatus 170 comprises a display configured to show one or more parameters associated with the Meakitements, for esatriple delta between SEM values derived from measurements taken at two bisyinmetric locations. [0057] Figure 4A depicts an exemplary SEM measurement apparatus 180 comprising two sensors 184A and 184B located at separate locations on apparatus body 182, accordingto the present disclosure. An example usage would be to place apparatus 180 against a patient's body (not shown) so as to simultaneously position first sensor 184A at a first location and position second sensor 184B at a second location, both on the surface of a patient's skin hi an aspect, apparatus body 182 is rigid and maintains sensors 184A and 184B at a fixed separation distance and fixed on minion W each other. In one aspect sensmis I 84A and 184B are aligned on a common plane, as shown in Figure 4A hi an aspect, apparatus body 182 is flexible such that sensors 1841. and 1846 may be oriented at an angle to each other. In one aspect, one or more of sensors I84A and 18411 arc movable such the angle between a mcw*able sensor and the other sensor may be varied, [0058] In use, apparatus 180 can measure an ebecical property or parameter that comprises one or more electrical characteristics selected from the group consisting of a resistance, a capacitance, an inductance, an impedance, a reluctance, and other electrical charactaistics with one or more sensors 184A and 1848. In an aspect sensors 184A and 184B are configured a; toroidal sensors such as shown in Figure IA, with center electrode 110 and ring electrode 120, In one aspect, sensors I 84A and 18413 are pmvided in other configurations as discussed in this applicafi cm to an aspect, sensors 184A and 1846 comprise an electrical ci plane (not shown) that is proximate to and separated from a portion of electrodes 110 and 120. In one aspect, a ground plane shields electrodes 110 and 120 from interference or modifies the shape of the field (similar in concept to field 140 of Figure IC) of sensors 184A and 18413. In an aspect a ground plane is disposed on a side of a substrate that is opposite The side OR Which electrodes 110 and 120 are disposed. In one aspect, apparatus 180 comprises a circuit (not shown) is electronically coupled to electrodes 110 and 12 each sensor 184A and 1840 and configured to measure an electrical propeny between electrodes 110 and 120, In an aspect, a ground plane is coupled to a ground a an equivalem floating reference of a circuit In one aspect, a circuit is configured to demmiine and provide information regarding the measured electrical property In an aspect. apparatus 180 takes the measurements with sensors 184A and 1846 essentially simultaneously.. In one aspect, apparatus 180 takes the measurements in sequence with a time interval between the measurements that ranges from zero to one second or more In an aspect, a measurement apparatus 180 is triggered by actuation of a 'button (not visible in Fiwie 44) is an actuator, hi one aspect, a measurement by apparatus, 180 is triggered automatically based on input from a switching clement (not shown in Figure 4A) that is part of apparatus 180, for example a contact SellSOF, a pressure sensor, an optical sensor, or other type of proximity-detecting device that is positioned, in an aspect, proximate to one or more of sensors 184A and 184B.

hi one aspect, molt le switching elements have to be. simul &men tsly activat to provide input to take [he measurement.

100591 In an aspect apparatus 180 comprise or (not shown) that is coupled to circuit and receive b Mformati oil about a meastued lectrical property from the circuit. In one aspect information is in the form of an anal oL....t signal, e.g. an electrical voltage, or a digital signal In an aspect, a processor's coupled directly to sensors 184A and 184B, and is configured to measure the electrical property directly. In one aspect, a processor is configured to convert the received electrical property into an SEM value, In an aspect,. a processor is configured by M achi ne-read abl e instnictions that are stored on a non-transitory, computer-readable medium that is electronically coupled to the processor. In one aspect tmctions are loaded from a medinin into a processor when apparatus 180 is powered on.

[00601 In an aspect, a measured electrical parameter is related to the in content of the epidermis of a patient at a depth that is determined bw the geometry of the electrodes of sensors.1:84A..,andl 18413, -the frequency and strength of electrical field 140, with reference to Figure 1C, that is created by sensors 184A and 1848" and other operating characteristics of apparatus 180. In one aspect, the moisture content is equivalent to the SEM content with a value on a predetermined scale. In an aspect, a predetermined scale may range from (Ho 20, such as from 0 to 1, from 0 to 2, from 0 to 3. from 0 to 4, from 0 to 5, from 0 to 6, from 0 to?, from 0 to 8, from 0 to 9, from (Ho 10, from 0 to 1I, from 0 to 12, from 0 to 13, frorn 0 to 14, from 0 to 15, from Ow. 16, from Ow 17, from 0 to 18. from 0 to 19. In one aspeO, a predetermined scaled can be scaled by a factor or a multiple based on the val Lie S provided herein. In an aspect, multiple measurements are ta -en while varying one or more of operating characteristics between readings, thereby providing information related to the tire content at various depths of the skin, [00611 In an aspect, measurements of capacitance are taken simultaneously with sensors 184A and 184B when contact sensors (not visible in Figure 4A) determine that sensors 184A and 18413 are in proper contact with two bisymmetric locations on a patient's skin. In an aspect, simultaneous capacitance measurements are compared to each other so as to determine whether the tissue under one of the bisyminetric locations is damaged. In one aspect, capacitance measurements are individually converted into SEM wattles that correspond to the moisture content of the tt sue that is proximate to respective sensors 1134A and Ii8413 and the SEM values compared, in aspeo, a comparison is performed using equivalent voltages, capacitance values, or other intermediate signals. 1.0.

100621 In one aspect, a difference between SEM values is determined, where a difference that exceeds a predetermined threshold is indicative or tissue damage at one of the locations where the corresponding capacitance measurements were taken. In an aspect, means of SEM values obtained at each bisyrnmetric locations are determined and compared. In one aspect medians or modes of SEM values obtained at. each hisymmetric locations are determined and compared hi an aspect, the damage is indicated to be at the location associated with the larger of the SEM -values. In one aspect, the damage is indicated to beat the location associated with the smaller of the SEM values. In an aspect determination of whether there is tissue damage comprises one Or more of comparison of individual SEM values with one or i.ci more predetermined ranges or thresholds and comparison of the Idiflrnee. with one or more predetermined ranges or thresholds. In an aspect, a predeterram'd range may be from 0.1 to 8.0, such as from 01 to I 0, from 1_1 to 2.0, from 2.1 to 3.0, from 3.1 to 4_0, from 4.1 to 5.0, from 5.1 to 6_0, from 61 to 7_0, from 7.1 to 8."0, from 0,1 to 75, from 0.5 to 8,0, from 1.0 to TO, from 1.5 to 6.5, from 2,0 to 6,0, from 3,0 to 5.5, from 3,5 to 5.0, or from 4.0 to 4 5, Juan aspect, a predetermined range may be from 0 1 to 4,0, such as from 0.5 to 4.0. from 0.1 to 3,5, from 1.0 to 3_5, from 1.5 to 4.0, from 1.5 to 35, from 2.0 to 4,0, from 2.5 to 3.5, from 2.0 to 3.0, from. 2.0 to 23, or from 2.5 to 3,0. In one aspect, a predetermined range may be from 4.1 to S.0, such as from 4.5 to 8,0, from 4. 1. to 7,5, from 5.0 to 7.5, from 5,5 to 7.0, from 5.5 to 75, from 6.010 8.0, from 6.5 to 7 5, from 6.0 to 7.0, from 6.0 to 6.5, or from 6.5 to 7 0. In range from 0.1 to 8,0, such as from 0,1. to 1.0" from 1,1 to 2,0, from 2. to 3 0, from 3.1 to 4,0, from 4.1 to 5_0, from 5.1 to 6.0, from 6, 1 to 7_0, from 7.1 to 8.0, from 0 I to 7 5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 210 to 6.0, from 3,0*to 5.5, from 3.5 to 5,0, or from 4.0 to 4,5. lin an aspect, a predetermined range or threshold can be scaled by a factor or a multiple based on the values provided herein. It ktill be understood that a predetermined 'alue is not li mited by design, but rather, one of ordinary 0,111 iII the art would be capable of choosing a predetermined value based on a given unit of SEM. In ono aspect, ranges and thresholds of the present disclosure are varlet". according -to the specific bi symmetric. locations, the portion of a patient's body ort which measurements are beinv made, or one or more one aspect, a predetermined threshold may be about 0,3, 0.35, 0.4, 0,45, 0.5, 0.55, 0,6, 0.65, 0.7. 0.75,.0.8, 0.85, 0.9, 0_95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1,7, 1,8, 1_9, 2,0, 2.1, 2,2, 2.3, 2.4, 25, 2.6, 2.7,2.;8, 219, 3,0, 3.1, 32, 33.1.4, 3.5, 3.6, 3,7, 3.8, 3.9, 4:0,4.1, 4.2, 4,3, 4.4, 4,5, 4,6, 4 7, 4,8, 4.9, 5,0, 5,1, 52, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6:0, 6,1, 6,2, 6,3, 6.4.6:5, 6.6,67, 6_8, 6.9, 7.0, 7,1, 7,2, 7.3, 7.4, or 7.5. In one aspect, a predetermined threshold may characteristics of the pa lent sly._ as age, height, weight family history, ethnic group; and other physical characteristics or medical condi 60/IS.

100631 One or mom rew'ons may be defined on a body In an aspect, measurements made within a region are considered comparable to each other. A region may be defined as an area on the skin of the body wherein measurements may be taken at any point within the area, In an aspect, a regioii corresponds to an anatomical region te.g,, heel, ankle, lower back). In an aspects a region may be defined as a set of two or more specific points relative to anatomical features wherein measurements are taken only at the specific points. In an aspect, a region may comprise a plurality of non-contiguous areas on the body. In an aspect, the set of specific locations m4 include points in multiple non-contiguous areas.

100641 In an aspect, a region is defined by surface area In an aspect, a region may be for example, between 5 and 200 cm2. between 5 and 100 cm between 5 and 50 cm2, or between 10 and 50 cm2, between 10 and 25 arr or between 5 and 25 cm2, 100651 In an aspect, measurements may be made in a specific pattern or portion thereat In 011 aspect, the pattern of readings is made in a pattern with the target area of concern in the center In an aspect, measurements are made in: one or more CiltIllaT patterns of increasing or decreasing size, T-shaped patterns, a set of specific locations, or randomly across a tissue or regi OM In an aspect, a pattern may be located on the body bsi defining a first measurement location of the pattern with respect to an anatomical feature with the remaining measurement locations of the pattern defined as offsets from the first measurement position.

[0066] In an aspect, a plurality of measurements are taken across a tissue region and the ifference between the lowest measurement value and the highest measurement value of the plurality of measurements is recorded as a delta value of that plurality of measurements. In an aspect, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more or more or 10 25 or more measurements are taken across a tissue or region, 10067] In an aspect, a threshold may be established for at least one region, In an aspect, a threshold of 0.2, 0.3, 0.4, 0.5, 06 07 0.8, 0,9, or other value may be established for the at least one region. In an aspect, a delta value is identified as significant when the delta value of a plurality of measurements taken).vithin a region meets or exceeds a threshold associated wi di that region. In an aspect, each of a plurality of tegions has a different threshold. In an aspect two or more regions may have a COMI11011threshold [0068] In an aspect, a threshold has both a delta value component a chronological component, wherein a delta value is identified as significant when the delta value is greater than a predetermined numerical value lot a predetermined portion of a time Finery al. In an aspect. the predetermined portion of a. time interval is defined as a mithiuum of X days wherein a plurality oftneasurements taken that day produces a delta value,greater than or cRmal to the predstermined numerical value within a total of Y contiguous days of measurement In an aspect the predetermined portion of a timennerval may be defined as I, 2, 3, 4, or 5 consecutive days on which a plurality ot measurements taken that day produces a delta value that is gr'eater than or equal to the predetermined numerical value. In an aspect, the predetermined portion of a time intenal may be defined as some portion.of a. different specific time period (weeks, month, hours etc)..

[0069] In an aspect, a threshold has a trending aspect wherein changes in the delta values of consecutive pluralities of measurements are compared to each other. In an aspect, a trending threshold is defined as a predetermined change in delta value over a predetermined length of time, wherein a determination that the threshold has been met Or exceeded is significant In an aspect. a detennination of significance will cause an alert to be issued In an aspect a trend line may be computed from a portion of the Mdividual measuremans of the consecutive I 5 pluralities of measurements hi an aspect, a trend line may be computed from a portion of the delta values of the consecutive pluralities of measurements.

[0070] In an aspect, the number of measurements taken within a single region may be less than the number of measurement locations defined in a pattern. In an aspect, a delta value will be calculated after a predetermined initial number of readings, which is less than the number of measurement locations defined in a pattern, have been taken in a region and after each additional reading in the same region wherein additional reading;:, are not taken once the delta value meets or exceeds the threshold associated with that region.

[00711 In an aspect, the number of measurements taken within a single region may exceed the =lib& of measurement locations defined in a pattern, In an aspect a delta value will be calculated after each additional reading.

100721 In an aspect, a quality metric may he generated for each plurality of measurements. In an aspect, this quality metric is chosen to assess the repeatability of the measurements, In an aspect, this quality metric is chosen to assess the skill of the clinician that took the measurements In an aspect, the quality metric may include one or more statistical parameters, for example an average a mean, or a standard deviation hi an aspect, the quality metric may include one or more of a comparison of individual measurements to a predefined range In rm aspect, the quality metric ma Y include comparison of the individual measurements to a pattern of values, for example comparison of the measurement values at predefined locations to ranges associated with each predefined location, In an aspect the quality metric may include determinarion of which measurements are made ever healthy tissue and one cn. more evaluations of consistency within this subset ellictal thy" measurements, for example a range, a Standard deviation, or other parameter [0073] In one aspeet, a measurement, for example, a Threshold value is determined by SEM Scanner Iklodel 200 (3rUill Biometrics, EEC, Los Angeles, CA). In another aspect. a measureinent is determined by another SEM scanner.

10074] In an aspect, a measurement value is based on a capacitance measurement by reference to a reference device, In an aspect, a capacitance measurement can depend on the location and other aspects of any electrode in a devit:e_ Such variations can be compared to a fCI reference SEM des*ice such as an SEM Scanner Model 200 (Btuin Biometrics, EEC, Los Angeles, CA). A person of ordinarv skill in the art understands that the measurements set forth herein can he adjusted to accommodate a difference capacitance range by reference to a reference device.

100751 In an aspect, apparatus 18.01$: capable of storing multiple measurement and computation results in one aspect, an apparatus in accordance with the present disclosure may also comprise other components, for example a camera or harcode scanner (not visible in Figure -1A), and may be capable of storing the output of that component. In an aspect, apparatus 180 comprises components (not visible in Figure 4A) to transfer the stored data, for example via a Bluetooth, WiFi, or Ethernet connection, to another device, for example a personal computer, server, tablet, or smart phone such as depicted in Figure U. [0076] Figure 413 depicts another aspect of an apparatus 186 that is configured to determine SEM values at bi symmetric locations. In an aspect, apparatus 186 comprises a hinge 188 such the separation distance betwten sensors 187A and 18711 may be Varied, In one aspect, sensors 184A and 184B are aligned with respect to apparatus body elements 186A and 1868 to achieve a desired relative orientation, for example parallel to each other, at a predetermined separation distance. Than aspect, one or rnore of sensors 187A and 18713 are movable such the angle betvveen the movable sensor and the other sensor may vary, for example to match the orientation of the skin under each of sensors 1.874 and 1878 as apparatus 185 is closed around an ankle to position sensors 187A and 1878 over locations 76R 'did 'OR shown in Figure 2C.

10077] Figure 5 depicts an exemplary mat assembly 190 comprising array 92 comprising a plurality of serisor5 90, according To the present disclosure, In one aspect, mat assembly 192 comprises a mat 200 ort which sensors 90 are disposed. In an aspect, sensors 90 are embedded within Ina 200. in one aspect, sensors 90 are located on the top surlime ofinat 200. In an aspect, son sots 901 have a cover layer (not visible in Figure 5) over them In one aSpeCi. SeTISOTS 90 COMpfice conductive electrodes that are exposed on their upper surface so as to create an electrical contact with an object proximate to the top of a mat, for example the feet of a patient standing on the mat, In an aspect sensors c./0 are toroidal sensors as shown in Figure IA. In one aspect, sensors 90 al e of a single time and configuration In ii aspect, sensors 90 vary in size and type within array 92. In one aspect, sensors 90 are of one or more alternate configurations, such as those discussed with respect to Figures 6. 7, SA, and MI In an aspect, mat assembh, [90 is coupled to an electronics assembly [92 either directly or through a cable 194, In one aspect an electronics assembly 192 comprises a circuit (not visible in Figure 4A) coupled to electrodes of sensors 90 and a processor (not visible in Figure 4A) coupled to the circuit, as discussed previously with respect to apparatus 180. [00781 In an aspect, mat assembly i9.0 comprises one or more of pressure sensors, temperature sensors, optical sensors, and contact sensors, (not visible in Figure 5) disposed at one or more respective locations across Mat 200, In one aspect one or more measurements using sensors 90 ate triggei-ed by input from one or inure of the pressure, temperat-ure, optical, and contact sensors [00791 In an aspect, mat assembly 190 is configured as a floor mat and actuation of one or more of the pressure, temperature, optical, and contact sensors, tbr example detection of a person standing on mat assembly 190 due to detection of the weight of a person by a pressure sensor, Mitiates a measurement by one or more of sensors 90. In one aspect, sensors 90 are operated in a "detection mode" that is capable of detecting when a person steps onto mat assembly 190 and transitions into a "measuretnent mode-upon determination that a person is standing on mat assembly 190 f0080] In an aspect, mat assembly [90 is configured as a portable apparatus that can be placed against a surface of a patient's skin, for example against patient's back or against the soles of one or both of their feet while the patient is lying in bed In one aspect, mat assembly 190 comprises one or more of 'a support tray, stiffening element, and conformal pad (not shown in Figure 5) to aid in placing sensors 90 against..a surface of a patient's skin.

j0081] Figure depicts an exemplary electrode array 290, according to the present disclosure.

'nay 290 is composed of individual electrodes 300 disposed, in this es.ample, in a regular Pattern over a substrate 299 in an aspect, each electrode 300 is separately coupled (through conductive elements not shown in Figures 6 through 88) to a circuit, such as described with respect to Figure 4A, that is configured to measure an electrical parameter. In one aspect, a "virtual sensor-is created by selective connection or predetermined subsets or electrodes 300 to a comrnon element of a Cfralii, In this example, a particular electrode 310 is connected as the center electrode., similar to electrode 110 of Figure IA, and six electrodes 320A-320F are connected together as a "viitual ring-electrode, similar to electrode 120 of Figure 1A. In an aspect, tWO individual electrodes are individually connected to a circuit to form 4 Virtual sensor, for example electrodes 310 and 3204 are respectively connected as the two electrodes of a sensor. In one aspect one or more electrodes 300 are connected together to loan one or the other of the electrodes of a two-electrode sensor.

[0082] Figure 7 depicts another exemplary array 400 of electrodes 410, according to the present disclosure, In this example, each of electrodes 410 is an approximate hexagon that is separated from each of the surrounding electrodes 410 by a gap 420. In an aspect, electrodes 410 are one of circles, squares, pentagons, or other regular or irregular shapes in one aspect gap 420 is uniform between all electrodes 410. In an aspect, gap 420 varies between various electrodes. In one aspect gap 420 has a width that is narrower than the cross-section of each of electrodes 410. In a,n aspe.ct, electrodes 410 may be interconnected to form virtual sensors as described below with respect to Figures 84 and 813 [00:83] Figure 84 depicts an array 400 of electrodes 410 that are configured, e.g. connected to a measurement circuit, to form an exemplary sensor 430, according to the present disclosure. In one aspect a single hexagonal electrode 410 that is labeled with a "1" forms a center electrode and a rittg of electrodes 410 that are marked with a 'IT. are interconnected to fomi a ring electrode. In an aspect, electrodes 410 between the center and ring electrode are dectrically 'floating!' In one aspect. dectrodes 410 between the center and ring electrode are grounded or connected to a floating ground_ ID an aspect, electrodes 410 that are outside the ring electrode are electlically Ifloatinn." In one aspect, electrodes 410 that are outside the virtual ring dectrode are grounded or connected to.a.floating ground.

[0084] Figure 813 depicts an alternate aspect where array 400 ofelectrodesA10 has been configured to form a virtual sensor 440, according to the present disclosure. In an aspect, multiple deetrodes 410, indicated by a -I," are interconnected to form a center electrode while a double-wide ring of electrodes, indicated.by.a -2: are imerconnected to fain a ring electrode In one aspect, various-numbers and positions of electrodes 410 are interconnected to form virtual electrodes of a variety of sizes and shapes.

10085 1 Figures 9A and 93 depict an exemplary configuration of an electrode array 400 that is capable of forming sensors 430 in multiple overlapping locations, according to the present disclosure. In Figure 9A. 'iirtual sensor 4304 has been formed with center electrode 432 formed by a single electrode.410, indicated by a " I, and a ring electrode 434 formed by a plurality of electrodes 410, indicated by a --. This same array 400 is shown in Figure 9113. where a new virtual sensor 430B has been formed with a center electrode 436, indicated by a -11.-and ring electrode 438, indicated by a -4 The position of virtual sensor 430A is shovem by a dark outline It can be seen that virtual sensor 43013 overlaps the position sensor* 430A, alknving measurements to be made at a finer resollitiOn than the diameter of sensors 430 100861 Figure 10 shows how sensors 430 may be formed from an at rav of electrodes 400 that is larger than the portion of a patient's skin that is being positioned against the array, accordina to the present disclosure. In this example, the outline of contact area 450 of 1C1 sole 22R of right foot 20R of a patient 10, as seen from underneath foot 20R and with referenceto Fipres 2A-2C, is shown overlaid I0nartay 400. In this example. sensor 430C has been formed in a location where a portion of sensor 430C eectends beyond the edge of contact area 450 In such a position, capacitance or other electrical parameter measured by sensor 430C is tower than capacitance rneasund by sensor 4301), which is positioned completely within contact area 450 It can he seen that a sensor 430 may be formed at any point within array 400 and depending on the position of sensor 430, may partially overlap the contact area at any level within a range of 0-100% [00/871 In an aspect, two sensors may overlap 0-50%, such as 040%. 5-15%, 10-20%, 15-25°,0, 20-30%, 25-35%, 30-40%, 35%-45°0, 40-50%, 0-25%, 15-35°0, or 255Q0 In one aspect, two sensors may overlap 25-75%, such as 25-35%, 30-40%, 35°0-45%, 40-50% 45¶5%, 50-60%, 55-65%, 60-70%, 65-75%, 25-50%, 40-55%, or 50-75% In one aspect tWO sexism may overlap 50-100%, such as 50-60%_ 55-65°10, 6040%, 6545°0, 70-80%, 75%-85%, 80-90%, 85-95%, 90400°0, 50-75%, 65-85°0, or 75-100% f01)8811 In one aspect, an array of sensors 400 may further comprise a plurality of contact sensors (not shown on Figure tO) on the same planar surface as, and surrounding, each of the electrodes to ensure complete contact of the one or more virtual sensors to the skin surface the plurality of contact sensors may be a plurality of pressure sensors, a plurality' of light sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of perspiration sensors, a plurality of ultrasonic sensors, a plurality of bone growth stimulator sensors, or a plurality of a Collibinalkil of these sensois In some embodiments, the plurality Of contact Sensors may comprise four, five, six, seven, eight, nine. Or tell Or more contact sensors surrounding each electrode, [01)89] Figures HA and JIB depict an example of ho:wccniparison if SENT -values associated with SellSOIS in known relative locations can identify bismineuric locations, according to the present disclosure. In this example, sensors 430 are formed at nonerlapping locations, marked "A" to.1.14-in Figwe 11A.. across a contact area 45OR of a right foot 2011 The SEM values measured at each location ate plotted in the graph of Figure 1 In this example, the SEAll,ialue of locations cA-and '14" are low or zero, reflecting the non-overlap of sensor 430 with contact area 450 in those locations. The SEM values associated with locations "B" and 16" are higher, as sensor 430 overlaps a portion of contact area 450 in those positions The ALM values for locations C-D-E-111 arc higher and, in this example, approximately the same, indicating that sensor 430 is completely within contact area 450 at those locations. In one aspect, an SEM measurement apparatus such as apparatus 180 may determine that certain locations, for example locations "C" and "F," are bisw-runetric with respect to a centerline 452R of tight foot 20R. In an aspect. where a similar set of measurements is made at locations Ai-FF cm left foot 20L a location on each foot 201, and 20R, for example locations E and E, may be determined to be approximately bisymmetric 100901 Figut-es 12A and 12B depict an exemplary aspect of a sensor assembly 500 configured to be placed in a known position on a patient's skin, according to the present discloswe In this example, sensor assembly 500 has a shaped substrate 510 that is configured to conform to posterior and bottom surfaces of heel of a foot 20, In an aspect, shaped substrate 510 may be suitable for use with both a left foot 20L and a right foot 20R In an aspect, sensor assembly 500 comprises one or more sensors 520 disposed on the inner surface of a shaped substrate 510. In this example, sensors 520 are configured as toroidal sensors as shown in Figure 1A. In one aspect. the inner surface of a shaped substrate 510 is lined with an array 400 of electrodes 410, with reference to Figure 7, such that virtual sensors may be formed at am. location In an aspect, sensors of other shapes and configurations are provided on the inner surface of a shaped substrate 510, In one aspect, shaped substrate 510 is a flexible panel (not shown in Figure 12A) that can be conformed to a patient s skin, for example wrapped around the back of an ankle. In an aspect, sensor assembly 500 comprises a cable 530 to connect sensors 520 to one or inure of a power source, a circuit configured to measure one or more of capacitance or other electfical property, a processor, a communication subsystem, Or Other type of electronic asset/1b1) (not shown in Figure 12A) 100911 Figure 1213 depicts an exemplary configuration of sensor assembly 500 where multiple sensors 520 disposed on shaped substrate 510 such that, for example when sensor assembly 500 is placed against the skin of a patient mound the buck and bottom of the right heel, sensors 520 will be positioned in locations 26R, 28R, and 30R, with reference to Figure 2C, as well..as on the center back of a heel. Thisenables multiple SEM measurements m he taken.ui.repetuable.ioeauon on a heel with sensor assembly. 500 in.a single position, In one aspect (not shown in Figures I2A and 12B), sensor assembly 500 is configured to be placed on a portion of the back of 4 patient thus pnwiding the capability to make measurements at bi symmetric locations on the back. In an aspect, shaped substrate 5 l 0 is configured to match anatomical features of the target area of a patient. In an aspect, a shaped substrate 5.1.0 comprises markings or other indicators that can be: aligned with features of.a. patient's body, so as to enable measurements to be taken at the same location at -time intervals over a period of time in the general range of hours to weeks. In one aspect, sensor assembly 500 is integrated into a lining of a garment or shoe or other article of clothing. In one aspect, sensor assembly 500 is integrated into a sheet, blanket, liner, or other tpe of bed clothing, In an aspect sensor assembly 500 comprises a wireless communication capability, for example a passive radio frequency identification (REM) or an inductive coupling, to allow actuation of sensors 520 -without physically connecting to sensor assembly 500.

10131921 Figui-e 13 depicts a schematic depiction of an integrated system 600 for measurement, evaluation, storage, and transfer of SEM values, according to the present disclosure. In this example, system 600 comprises: a SEM measurement apparatus 180, as discussed with respect to Figure 4A, that compUses the capability to wirelessly communicate with a NM Fi access point 610. Apparatus 180 communicates with one or more of a SEM application running on a server 640, an application running on a laptop computer 620. a $mart phone 630. or other digital de ice.. In one aspect, laptop computer 620 and smart phone 630 are carried by a user of apparatus 180, for example a nurse, and an application 'Provides feedback and information to the user, In an aspect, information received from apparatus 180 for a patient is stored in a database 650. In one aspect, information received from apparatus 180 is transferred over a network 645 to another server 660 that stores.a portion of information in an electronic medical record (ENIR) 670 of a patient In one aspect, information from apparatus or veci from database 650 or Elva o7o is transferred to an external server 680 and Men to a computer 685, for example a computer at the office of a doctor who is providing care for a patient.

100931 From die foregoing, it will be appreciated that the presenL iflsOUbofl cmi be embodied in various ways, which include but arc not limited to the following: f06941 Embodiment 1 An apparatus for identifying damaged tissue, the apparatus comprising: a first sensor and a second sensor, where the first and second sensors each comprises a first electiode and a second electrode, and where each of the sensors is con figured to be placed auiti fist a patient's skin_ a circuit electronically coupled to the first and second clectrodc,s and configured to measure an electrical property between the first and second electrodes of cach of the sensors and provide infomiation reek-in-line the electrical properly a processor electronically coupled to the circuit and configured to receive the inlbrmation from the circuit and convert the information into a sub-epidermal moisture (SEM) value., and a non-transitory computer-readable medium electronically coupled to the processor and comprising instructions stored Macon that, when executed on the processor, perform the step of determining a difference between a first SEM value corresponding to the electrical prepeny as measured by the first sensor at a first location on the patient's skin arid a second SEM value cot-responding to the electrical propel ty as measuied by the second sensor at a second location on the patient's skin, where the second location is bisyrametric relatne to the first location.

[0095] Embodiment 2 The apparatus accordinu toettliment 1. where the difference being greater than it predetermined threshold is indicative of damaged tissue at one of the. first and secon( locations: s.

[0096] Embodiment 3, The apparatus according to embodiment 1, where: the circuit is electronically coupled to the first and. second electrodes of each of the first and second sensors, and the circuit is configured to convert a first electrical property measured with the first sensor Mto the first SEM value and convert a second electrical property measured with the second SUMO"' into the second SEM value.

[0097] Embodiment 4. The apparatus according to embodiment 2, further comprising: a substrate configured to be placed in a known position on the patient's skin, and the first and second sensors are disposed on the substrate such that the first and second sensors are positioned at bisymmetric locations on the patient's skin when the substrate is placed in the 'mown position on the patient's skin.

100981 Embodiment 5. 'the apparatus accord* to embodiment 1, further comprising a gap between the first and second electrodes.

100991 Embodiment 6. The apparatus according to embodiment 1, where the electrical property comprises one or -mom of an electrical component selected from the group consisting of a resistance, a capacitance, an induetance, an impedance, and a reluctance.

011001 Embodiment 7. An apparatus for identifying damaged tissue, said apparatus comprising: a substrate configured to be placed against a surface of a patient's skin; a plurality of sensors that are disposed on said substrate at a respeeti%e plurality of positions, wherein each sensor comprises a pair of electrodes; a circuit electronically coupled to said of electrodes of each of said plum ity of sensors and configured to measure an elec cal)erty between said pairs of electrodes of a. portion of said plurality of sensors and provide ation regarding said measured electrical properties; a processor electronically coupled to said circuit and configured to receive said information regarding said electrical properties said circuit and convert said plurality of electrical properties into a respective plurahly of sub-epidermal moisture (SEM) values; and a non-transitory computer-niadable medium electronically coupled to said processor and comprising instructions stored thereon that, executed on said processor, perform the steps of identifying from said plurality of SEM values a first sensor and a second sensor that are located at first and second positions that are 10 bisymmetric with respect to said patient's skin, and comparing a first SE.M value that is associated with.sad st sensor with a second SEM value that is associated with said second SCTISOT.

10101] Embodiment 8 The apparatus according to e Thodiment 7_ wherein said instructions further comprise the steps of determining a difference between said first and second SEM 1 values and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold.

10102] Embodiment 9. The apparatus according to embodiment 7, wherein said instructions further comprise the smps of; determining a difference between said first and second SEM Values, determining which of said first and second SEM values is larger than the other, and providing an indication that tissue is damaged at the location associated with the larger SEM value if said difference is greater than a predetermined threshold.

[01031 Embodiment 10. The apparatus according to embodiraent 7, \\Therein said electrical property comprises one or more of an electrical component selected from the group consisting. of a resistance_ a capacitance, an inductance, an hnpedance, and a reluctance. 25 101041 Embodiment IL An apparatus for identifying damaged tissue. the apparatus comprising: an apparatus body; two sensors comprising a first sensor and a second sensor, wherein said two sensors are disposed on said apparatus body to allow simultaneous positioning of said first sensor on a first location on a patient's skin and said second s sor on a second location bis3mmictric relative to said first location; a circuit electronically coupled to each of said two sensors and configured tomeasure an electrical property from each of said two sensors; a processor electronically coupled to said circuit and is configured to receive a first electncal property measurement from a first location and a second electrical property utensil/tine/I fi:oin a second location, and to convert said first electrical property measurement to a first sub-epidermal moisture 041M) value and said second.elect eal property measurement to a second SENtvalue; a nun-transitory vompuLer-ieaduble iedium. electronically.coupled to said processor and contains instructions that; when a:caned on said processor, perform the step of determining a difference between said.first SyM value 004 saias&brAti Om value: [0105] Embodiment 12. -fhe apparatus according) ibodiment 11, wherein each of said s arc disposed on two ends of said apparatus: 'Jody while being aligned on a common plane.

[0106] Embodiment 13 The apparatus according to embodiment 11, wherein said apparatus body is rigid and maintains said two sensors at a fixed separafion distance and fixed*10 orientation to each other.

[0107] Embodiment 14. The appat atus aecordmg to embodiment 11, herein said apparatus body is flexible and allows said two sensors to he oriented at an angle to each other.

1-01081 Embodiment 15 The apparatus according to embodiment 14, wherein said aP:at us body comprises a hinge.

1 101091 Embodiment 16-The p according ttiemhpdimerit.. 11 wherein each of said two sensors COrripriSeS a first electrode.and.a second electrode separated by a gap- 10110] Embodiment 17. The apparatus according to embodiment 16, wherein said electrical property is measured between said first electrode and said second electrode.

[01111 Embodiment 18. The apparatus according to embodiment 11, vdierein each of said two SCHS°15 comprises a plurality of electrodes separated bY a ga-P- [0112] Embodiment 19. The apparatus according to embodiment 18, wherein said pluraht3 of electrodes are selectively activated to form a virtual electrode and a virtual c.e.nttal electrode.

[01131 Embodiment 20-The apparatus according to embodiment 11. \therein said electrical 25 property compfises one or more of an electrical characteristic selected from the group consisting of a resistance, a capacitance, an inductance an impedance, and a reluctance, 0114] EinhOdithent 21, The apparatus according to embodiment 11 Wherein said fist electrical property measurement and. said second electrical property measurementare measured simultaneously, inny.9 Embodiment 22,11c apparatus according toembodiment.2 E. wherein f,;aict apparatus further comprises a contact: sensor positioned pro'mnae to one of said ONO sensors, and Wherein Said Simuharientis meastlrOntent1i are triggered:by the aCtuationxitSaid contact SenSini.

[01161 Embodiment 23. The apparatus. according to embodiment 2,12" .Wherein sai4coniat sensor is. a pressure sensor or an optical sensor, [01171 Emborlitueut 24. The apparams.according to.embodiment 11Wherein aid instructions furMer comprise the step of providing an indication.thattissne is damaged at one of said first and second locations if Me difference is greater than a predetermined threshold. 01181 Embodiment 25. 'The apparatus according to anbodiment 11, wherein said instructions further comprise the steps of: determining_ the greater of said first and second SEM values, and providing an indication that tissue is damaged at the location associated with the greater SEM value if the difference exceeds a predetermined threshold, [01191 Embodiment 26. A method for identifying damaged tissue,The 'method coin obtaining a first sub--epidermal moisture (SEM) value from a first location on a.patients skin; obtaining a second SEM value from a second location that is bisymmetric relative to said first location: determining a difference between said first SEM value and said second SEM value. [01201 Embodiment 27. 'The method according to embodiment 26, thrther comprising providing an indication that Tissue is damaged at one of said first and second locations it aid difference is greater than a predetermined threshold.

[0121] Embodiment 28. The method according to embodiment, further comprising: deteomning the greater of the first and second SEM values, and providing an indication that tissue is damaged at the location associated with the greater SEM value if the difference exceeds a predetetmmed threshold.

[0122] Embodiment 29. An apparatus for n dying damaged tissue, said apparatus comprising: a first sensor and a second sensor, each Ieoriiiig a first electrode and second electrode, and wherein said first sensor is configured to he placed against a first location on a patient's skin and said second sensor is configured to be placed at the same time against a second location on said patient's skin, wherein said second location is bisymmetric relative to said. firstlocation; a circuit electronically coupled to said first electrodes and said second electrodes and configured to measure a first electrical property between said first and second electrodes of said first sensor and to measure a second electrical property between said first and second electrodes of said second sensor and provide information regarding said first and second electrical properties" a processor electronically coupled to said circuit and configured -ve said information: and a non-transitory computer-readable medium electronically c4iupled to said processor and comprismg instructi011s stored thereon that, when executed on processor, perform the steps of converting said first electrical property into a first sub--epidermal moisture (SEM) value and said second electrical property into a second SEM value, and determining a difference betweenyaid [irs SFM value and 14a1d second SEM value.

101231 EmhxUment 30: The apparatus according to embodiment 29, wherein instrukAions ftirthei comprise a st predetermined threshold. 01241 1:nabodiment 31: Ffic.., I providing a signal if said difference is greater th..m iaratus according to club° ment 29, her ecmprsbag switching element configured to detect when said first and second sensors arc in proper contact with said patient's skin wherein: said circuit is electronically coupled to said switching element and configured to measure said that and second electrical Properties'when said first and second sensors are in proper contact with said patient's skin.

101251 Embodiment 32: The apparatus according to embodiment 30, further compti suhtrate.*configured1 to be placed in a known position on said patient's skin; and said first and second sensors are disposed on said substrate such that said first and second sensors are positioned at bisymmetfic locatious on said patient's skin when said substrate is placed in sa known position on said atient's skin.

[0126] Embodiment 33: The apparatus a.ccordin, to embodiment 29, further camp gap between said first and second electrodes.

[01271 Embodiment 34; The apparatus according to embodiment 29, wherein said electrical property comprises one or more of an electrical component selected from the group consisting of a resistance, a capacitance, an inductance, an impedance, and a reluctanct.

[0128] While the invention has been described with refeTence to particular aspects, it will be understood by those skilled in the art that vanous changes*may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention ln addition, many modifications may be made to a particular situation or material to the teachings of the invention without departing from the scope of the invention. Therefore, it is intended that the invention not be limited to the particular aspects disclosed but that the invention will include all aspects failing within the scope and spirit of the appended claims.

Claims (4)

1. CI VMS1. An apparatus tar identity ng damaged tissue, said apparatus compn sing an apparatus body.two sensors comprising a first sensor and a second sensor, each sensor comprising a Lust electrode and a second electrode wherein said rwo sensors are disposed on said apparatus body to allow simultaneous positioning of said first sensor on a first location on a patient's skin and said second sensor on a SCCand loeadon hisymmetrie relative to said first location, and -wherein said apparatus body is rigid and maintains said two sensors at a fixed separation distance and fixed orientation to each other, a circuit elect; a first electricalproperty-from said first:tsor Id second sensor:, Wherein -said first Clectri electrn.at property are measured simultaneously.; 15.a processor electronically coupled to said circuit and is co.nfwure.d to receive said firSt electrical property measurement from said t location and said second electrical property measurement from said second location, and to convert said first electrical property Measurement to a first sub-epidermal moisture (SEM) value and said second electrical property measurement to a second SEM value; anon-transitory computer-readable medium electronically coupled to said processor and contains instructions that, when executed.011 said processor, perform the step of determining a difference between said first SEM value and said second SEM value, wherein the difference exceeding a predetermined threshold is indicative of tissue damage at said first location or said second location.
2. 25. 2; The.apparatus according to claim 1, wherein each of said two sensors are disposed on ends of said apparatus body while being aligned on a common plane.
3. 3. The apparatus according to claim 1., wherein each of said two sensors p es a firs electrode and a second electrode separated by a gap.
4. 4. The apparatus. according to claim-d, wherein said each.of said first electrical property and :said second -electrical property is ineasnind he said fimtelectrodeand..said.secamd eleetrode.its art4. configured to measuie second electrical property iperty and said second 5. The apparatus ing to claim 1, wherein, At ofsakl. twosn omp3.plurality of electrodes separated by a aup.The apparatus according to claim 5, wherein said plurality otele,ctrodesare. selec activated to form a 'virtual ring electrode and a virtual central electrode, 7. The apparatus according to claim 1, wherein said first electrical property comprises one or more of an electrical characteristic selected from the group consisting of a resistance, a capacitance, an inductance, an impedance. and a reluctance.8 the apparatus according to claim 1, wherein said second electrical property omprise one or moreS of an electrical characteristic selected from the group consisting of a resistance, a capacitance, an inductance, an impedance, and a reluctance.9 Prti g to claim 1;witcrcin s.uid apparatu fiuther coniprises.a contact r positioned pioxirnate t one 0 I said two SCPSOISb and wherein said simultaneous, measurements are Lriggered hythe..actoattan cif said coranot sensor.10, The apparatus according to claim 9, wherein said coi.apressure.sensor Oran optical SeilSOT.The.apparatus according.chtiti 1, Wherein st-ild iristr.ioris. further comprise the tetl) of providing.an.:indication that tissue is damaged at one of said st and second locations if the.-difference is greater than a predetermined-threshold.12 The apparatus according to chum 1, wherein d instructions further compri the steps of: determining the greate.rof said first and second SEM values, and providing an indication that tissue is damaged at the location associated with the ovater SEM value if the difference exceeds a predetermined threshold.The apparatus according to. claim1, wherein said first electrical property co.mprise.s 23 capacitance, and said second electrical property comprises a capacitance.